Micro-X Ltd. Recall 95603
Description: MICRO-X Rover Mobile X-ray System, # MXU-RV35
Micro-X Ltd. Recall 95603 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0664-2025 |
Event ID | 95603 |
Event Description | MICRO-X Rover Mobile X-ray System, # MXU-RV35 |
Product Type | Devices |
Distribution | Worldwide and US Nationwide Distribution: NJ, PR, CA |
Quantity | 5 |
Recall Reason | Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started. |
Device Classification | 20241218 |
Device Code Info | UDI-DI: 9357123000037. Serial Numbers: 00334, 00348, 00349, 00351, 00361.¿ |
Center Classification Date | 20241212 |
Recall Initiation Date | 20230531 |
Recalling Firm | Micro-X Ltd. |
Initial Notification | Letter |
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